esion Characteristics after Pulsed-Field Ablation in Patients with Atrial Fibrillation and a Left Common Ostium (PFALCO RE-MAP STUDY)
- Conditions
- Atrial fibrillation10007521
- Registration Number
- NL-OMON56175
- Lead Sponsor
- OLVG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
- Age > 18 years of age on the day of enrolment of either sex
- Willing to sign informed consent
- Left atrial volume index measured < 60 ml/m2 within last 12 months
- Documented atrial fibrillation
- Admitted and accepted for PVI
- A left common ostium of the pulmonary veins identified by CT or MRI
- Accepted to receive general anaesthesia
- Patients age < 18
- Body mass index > 35kg/m2
- Left atrial volume index >= 60 ml/m2 within 12 months on MRI or cardiac echo
- New York Heart Association heart failure class III or IV
- Myocardial infarction within three months before the procedure
- Unstable angina pectoris
- Percutaneous coronary interventions within three months before the procedure
- Sudden cardiac death event within three months before the procedure
- Life expectancy of less than one year
- Presence of an atrial tachycardia other than cavotricuspid isthmus dependent
atrial flutter
- History of blood clotting or bleeding abnormalities
- History of a thromboembolic event within six months before the procedure
- A contraindication to anticoagulant
- Clinical significant infection
- Unstable clinical significant medical condition
- Previous left atrium ablation, except successful accessory pathway ablation
- Presence of a left appendage closure device
- Presence of an atrial septum occluder
- Presence of a prosthetic heart valve
- Occlusion of the inferior venous tract
- Enrolment in another study that would interfere with this study
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method